1. Field of the Invention
This invention relates to a package for a drug-device combination product having an outer package including a first gas impermeable sheet, a second gas impermeable sheet and a gas permeable header.
2. Discussion of the Related Art
Packaging a product in an inner package and then packing the inner package in an outer package is common in the packaging arts. Vacuum packaging, packaging with an inert gas and multiple methods of sterilizing medical products are known in the medical device packaging art. However, drug-device combination products offer a new and unique problem in the packaging and sterilizing of the product, while refraining from altering the chemical structure of the drug incorporated in the device.
Numerous inventions relate to the use of radiation to sterilize products for medical use, for example, U.S. Pat. No. 5,577,368 to Hamilton et al. (“Hamilton”) and U.S. Pat. No. 6,174,934 to Sun et al. (“Sun”). Both Hamilton and Sun first remove the oxygen/atmosphere from the packaging prior to radiation sterilizing medical implants made of polymeric material. Hamilton's and Sun's goal is to reduce the wear resistance of the polymeric implant and, radiation typically alters the chemical structures of incorporated drugs.
Other inventions known in the art require numerous complex steps to sterilize and seal a medical device in one or more packages. U.S. Pat. No. 4,709,819 to Lattuada et al. discloses first sterilizing an outer package, placing an inner package in the outer package and then evacuating both the inner and outer packages. This process is used because Lattuada et al. are packaging biological samples and any sterilization of the inner package would kill the sample.
Further, U.S. Pat. No. 4,941,308 to Grabenkort et al. discloses sterilizing the interior of the package before placing the product in the inner package, sterilizing the product in the inner package, and then placing the inner package in the outer package. Additionally, Grabenkort et al. uses ethylene oxide gas (EtO) for the sterilization.
Both Lattunda et al. and Grabenkort et al. require a separate sterilizing step prior to inserting and sealing the inner package in the outer package. This adds steps and cost to the handling of the already sterilized product/inner package prior to inserting it into the outer package.
Thus, there is a need in the art for a packaging product and method to sterilize a drug-incorporated device in the minimum number of steps while refraining from altering the chemical structure of the drug incorporated in the device.